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FDA ANDA · ANDA200386
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Sponsor: COSETTE PHARMS NC
APPLICATION
ANDA200386
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
LATEST ACTION
2025-12-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEPrescription
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-29Labeling · Supplement 19 · standardAP
2023-12-15Labeling · Supplement 16 · standardAP
2023-12-05Labeling · Supplement 9 · standardAP
2018-06-28Labeling · Supplement 8 · standardAP
2018-06-26Labeling · Supplement 5 · standardAP
2017-08-29Labeling · Supplement 4 · standardAP
2017-01-13Labeling · Supplement 3 · standardAP
2013-05-10Labeling · Supplement 2 · standardAP
2012-06-29Not Applicable · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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